The MDR Guidebook

An essential tool for any device manufacturer selling into Europe

With the EU Medical Device Regulation (MDR) looming and requiring implementation by 2020, we have created a guidebook and training course to help you get prepared.

 

For anyone involved in ensuring compliance with the EU MDR, it is the ‘go-to’ reference and tool kit, intended to be your companion to reference time and time again.

It contains a number of useful tools and tables to guide you through the MDR, such as:

 

  • device classification and their differences from the MDD

  • QMS requirements and how they align with ISO 13485

  • technical documentation requirements

  • clinical data requirements, including a handy checklist

  • general safety and performance requirements tables

  • annex and article guide

 

 

 

 

Front cover Meddev MDR Book 2018 Hi Res
front page from RAPS MDR Book 2018 Hi Re

Product Info

£225 (exc VAT & Shipping)
 
380 Pages
 
Sample
 

Ebook available now

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RAPS has teamed up with us to offer our MDR Guidebook in a convenient e-book format.

*Note: Internet access is required to read all RAPS e-books. E-books cannot be downloaded for offline use. 

RAPS Member: $175
Non-memeber:  $225

© 2019 Meddev Solutions Ltd

Company Registration NI645349

Newry

BT34 2DL

United Kingdom

VAT no. 267 7231 82

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